105年度疫苗與類毒素檢驗封緘案件分析

Annual Surveillance of Batch Release: Vaccines and Toxoids in Taiwan, 2016

莊沛樺(PEI-HUA CHUANG) ； 張欣如(HSIN-JU CHANG) ； 林孟潔(MENG-CHIEH LIN) ； 許家銓(JIA-CHUAN HSU) ； 楊依珍(YI-CHEN YANG) ； 曾素香(SU-HSIANG TSENG) ； 王德原(DER-YUAN WANG) ； 陳惠芳(HWEI-FANG CHENG)

《食品藥物研究年報》 8期 (2017/11) Pp. 339-343

摘要

本研究報告統計並分析食品藥物管理署(以下簡稱食藥署)105年度經檢驗合格封緘完竣之疫苗與類毒素，以瞭解國人使用之疫苗與類毒素整體概況。105年度食藥署共放行封緘210批次10,896,187劑疫苗與類毒素，其中國產58批次4,122,437劑，批次及劑量數各佔27.6及37.8 %，國外輸入152批次6,773,750劑，批次及劑量數各佔72.4及62.2 %。經進行23項目3,432次檢驗及審查，結果均符合原廠與國際間藥典規格。由檢驗封緘放行之劑量數逐月趨勢顯示，9月份因應季節流感疫苗採購劑量增加，為全年度劑量數最高峰之月份。若依疫苗及類毒素類別進行分析統計，放行劑量數前3名依序為流感疫苗、五合一疫苗(白喉、破傷風、非細胞型百日咳、b型嗜血桿菌與不活化小兒麻痺混合疫苗)及A型肝炎疫苗，放行批次數前3名依序為流感疫苗、人類乳突病毒疫苗及日本腦炎疫苗。

關鍵字

疫苗 ； 類毒素 ； 檢驗封緘

並列摘要

This report shows the statistical analysis results of the batch release of imported and domestic vaccines and toxoids by the TFDA in 2016. Two hundred ten batches of vaccines (10,896,187 doses) were released in Taiwan in 2016. The proportions of batches and doses for domestic products were 27.6 % (58 batches) and 37.8% (4,122,437 doses), respectively, while the proportions for imported products were 72.4% (152 batches) and 62.2% (6,773,750 doses), respectively. In totally, 3,432 tests covering 23 items were performed. All of the test results complied with the manufacturers' specifications or acceptance criteria of the international pharmacopoeias. From the monthly trend analysis, the largest number of doses released was in September. In terms of the number of doses released, the top three vaccines and toxoids were Influenza vaccine, 5-in-1 vaccine (Diphtheria, Tetanus, Pertussis (Acellular, Component), Poliomyelitis (Inactivated) and Haemophilus influenzae type b) and Hepatitis A vaccine. In terms of the number of batches released, the top three vaccines and toxoids were Influenza vaccine, HPV vaccine and Japanese encephalitis vaccine.

並列關鍵字

vaccine ； toxoid ； batch release